U.S. patent application number 12/964216 was filed with the patent office on 2011-03-31 for system and method for assisting in the home treatment of a medical condition.
This patent application is currently assigned to Novo Nordisk A/S. Invention is credited to JENS BJERRE KNUDSEN, Amy D. Shapiro.
Application Number | 20110077963 12/964216 |
Document ID | / |
Family ID | 42541136 |
Filed Date | 2011-03-31 |
United States Patent
Application |
20110077963 |
Kind Code |
A1 |
KNUDSEN; JENS BJERRE ; et
al. |
March 31, 2011 |
SYSTEM AND METHOD FOR ASSISTING IN THE HOME TREATMENT OF A MEDICAL
CONDITION
Abstract
An interactive home treatment system and method is disclosed.
Patient data is collected via a handheld device and stored in a
database. The data may be related to self-treatments, symptoms, or
patient behavior. The data are analyzed with an analytic tool and
the analysis is used to generate a message that is transmitted to a
treating health care professional or to the patient, or both. A set
of predetermined rules may be applied to the data. The rules may be
modified by the treating health care professional, the patient, or
both. The handheld device, the database, and the analytic tool may
be web-enabled to facilitate communication from virtually
anywhere.
Inventors: |
KNUDSEN; JENS BJERRE;
(Farum, DK) ; Shapiro; Amy D.; (Indianapolis,
IN) |
Assignee: |
Novo Nordisk A/S
Bagsvaerd
DK
|
Family ID: |
42541136 |
Appl. No.: |
12/964216 |
Filed: |
December 9, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12701948 |
Feb 8, 2010 |
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12964216 |
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10743621 |
Dec 22, 2003 |
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12701948 |
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10438543 |
May 15, 2003 |
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10743621 |
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60381011 |
May 15, 2002 |
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Current U.S.
Class: |
705/2 |
Current CPC
Class: |
Y02A 90/10 20180101;
G16H 20/17 20180101; A61B 5/4833 20130101; G06Q 10/06 20130101;
G16H 40/67 20180101; G16H 10/60 20180101 |
Class at
Publication: |
705/2 |
International
Class: |
G06Q 50/00 20060101
G06Q050/00 |
Claims
1. A method of transmitting information about a bleeding disorder
to a healthcare provide for use with one or more patients having
bleeding disorders, the method comprising the steps of: providing
the patient with a handheld device having a monitor with a touch
screen and a processor; displaying on the monitor a question
indicative of whether the patient has taken a hemostatic medication
prior to a bleeding episode; receiving an answer from the patient
as to whether a medication was administered before the bleeding
episode began; displaying on the monitor a question indicative of
the time from the initial occurrence of the bleeding episode to the
time of an infusion of an hemostasis product; receiving an answer
from the patient as to the time of the bleeding episode to the
infusion; displaying on the screen one or more pictures of the
human body; instructing the patient to indicate where bleeding is
occurring by touching the picture in a location representative of
the actual bleed; receiving from the patient information as to the
patients response to the infusion; transmitting from the handhand
held device to a centralized database at a location accessible to a
healthcare provider information relating to location of the
bleeding episode, time from onset of the bleeding episode to
infusion, response to the infusion.
2. The method of claim 1 further comprising registering information
about infusions of hemostasis agents from one of the patients
having a bleeding disorder, wherein the information is entered via
the handheld device and wherein the information entered comprises
on or more of the following: reasons for an infusion of a
hemostasis product, number of infusions given in a predetermined
time period, or number of bleeding episodes since last infusion of
a hemostasis product.
3. The method of claim 1 where the patient is instructed to operate
the device contemporaneously with a bleeding episode.
4. A system for collecting data relating to treating a patient
having a bleeding disorder, the system comprising a handheld device
having a touch screen display that displays one or more figures of
the human body, an input mode for allowing a patient to enter
location of a bleed by touching a corresponding part on the figure
of the human body, the input mode allowing for entry of data
relating to time from bleed to start of infusion of a
self-administered hemostasis product and the input mode allowing
for input of data relating to the success of the infusion in
affecting the bleed, the system being configured to transmit data
collected by the handheld device from the patient to a centralized
processor, the centralized processor configured to compile data
from multiple handheld devices.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 12/701,948 filed Feb. 8, 2010 (pending), which is a
continuation of U.S. application Ser. No. 10/743,621 filed Dec. 22,
2003 (abandoned), which is a continuation of U.S. application Ser.
No. 10/438,543 filed on May 15, 2003 (abandoned), and claims
priority under 35 U.S.C. 119 of U.S. provisional application No.
60/381,011 filed May 15, 2002, the contents of all of which are
fully incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to methods and systems for
interactive home treatment of chronic and/or episodic diseases.
While the present invention is particularly useful in the field of
hemophilia, it is also useful with other chronic and/or episodic
diseases and is therefore not limited to one particular field.
BACKGROUND OF THE INVENTION
[0003] Advances in medical technology and the rising costs of
medical care have resulted in an increasing number of patients who
self-administer medications and treatments outside of a doctor's
office or a medical facility. The success of such treatments,
however, depends on appropriate patient compliance and carries the
risk of under-treatment, over-treatment, or inappropriate
treatment. Thus, there is a need in the art for methods and systems
that facilitate home treatments and enhance their overall safety,
efficacy, and cost-effectiveness.
[0004] In the field of hemophilia, for example, most patients visit
a hemophilia center infrequently and treat bleeds at home through
self-administration of medication. Some studies have shown that
more than 80% of hemophilia drugs are used outside clinics and
hospitals. The regular and systematic evaluation of home treatment
is therefore critical to patient welfare and treatment
optimization.
SUMMARY OF THE INVENTION
[0005] The present invention provides methods and systems for
interactive home treatment of patients, including, without
limitation, those suffering from diseases or syndromes that are
chronic and/or episodic. The present invention provides for a
personalized system for rapidly transmitting individual treatment
data over a communications network to a treatment center, thus
facilitating earlier identification of clinical problems. A
hand-held, pocket PC or a personalized secure website may be used
to enter data. The data may be encrypted to ensure patient
confidentiality.
[0006] When used in the field of hemophilia, for example, the data
collected include pertinent information on the time and date of an
infusion of a treating agent, batch number of product, reasons for
the infusion, product used, site and type of bleed (using a
detailed and versatile body figure), response to infusion, etc.
Data input can be augmented through use of drop-down menus, pop-up
screens, and easily interpreted questions and suggested answers.
Systems can be designed to allow data entry in under one minute per
infusion. And the system can be configured to allow patients to
communicate and hold discussions with treating centers.
[0007] A computerized system analyzes incoming data and flags any
deviation from established center standards and criteria. In
addition, individual or combined patient data can be analyzed to
allow easy evaluation of resource utilization, patient compliance,
and response to therapy.
[0008] In some embodiments, patients/parents can use the system to
analyze their own past data as graphs or tables.
[0009] Data can be integrated into a large database and analysis of
data from many patients and/or centers can be combined and
analyzed.
[0010] In some embodiments the methods of the present invention may
be carried out by: (a) collecting information from the patient
regarding one or more episodes related to the syndrome and (b)
analyzing the information by identifying the presence or absence of
predetermined patterns in the information. The methods may further
comprise providing feedback to the patient based on the analysis.
The information may relate to one or more of: the following: (i)
the nature, severity, and/or timing of symptoms, wherein the
symptoms may comprise one or more clinical indicators; (ii) one or
more predisposing factors that are predictive of onset of an
episode; (iii) one or more actions related to treatment that have
been self-administered by the patient and/or administered to the
patient by a surrogate; and (iv) one or more changes in the
symptoms, indicators, factors, or actions over time.
[0011] In one aspect, the collecting and/or providing step is
achieved using a microprocessor having storage means capable of
storing the information, an input means, a display operationally
connected to the microprocessor, and a means for transmitting the
information to a second device; and the analyzing step is achieved
using a central computer capable of receiving and analyzing the
transmitted information and providing the feedback. In one series
of embodiments, the collecting step comprises entry by of the
information by the patient using a handheld computer.
[0012] In another aspect, the invention encompasses applying one or
more rules to the collected information, in order to identify
patients requiring particular types of feedback or intervention.
The rules may be, e.g., general rules, group rules, or individual
rules. Non-limiting examples of such rules include: (i) a specified
threshold time interval during which the patient has not reported
any data; (ii) a specified threshold time interval from onset of a
particular symptom to administration of treatment; (iii) a
specified threshold number of self-treatment actions to treat one
particular episode; and (iv) a specified clinical outcome of the
episode.
[0013] In another aspect, the invention encompasses repeating the
collecting and analyzing steps in order to further refine and/or
develop the rules, which may be modified for a single patient or
groups of patients based on repeated collection and analysis of
information.
[0014] In one series of embodiments, the invention provides a
method for assisting in the treatment of a disease, which is
carried out by the steps of: (i) collecting from a plurality of
patients information relating to symptoms and/or self-treatment of
the disease via a handheld electronic device; (ii) transmitting the
information collected by the handheld device to a database; (iii)
analyzing the data in the database; (iv) providing the results of
the analysis to a health care professional treating one of the
plurality of patients; (v) receiving from the health care
professional a message for the one patient; and (vi) transmitting
the message to the one patient's handheld electronic device.
[0015] In another aspect, the invention encompasses systems for
assisting a health care professional in managing the treatment of a
particular patient suffering from a disease, which comprises: (i) a
plurality of patient interface devices for collecting data from a
plurality of patients, transmitting the data, and receiving
instructions relating to treatment of the disease; (ii) a database
for storing the data; (iii) an analytic tool for analyzing the data
in the database and providing an analysis specific for the
particular patient to the health care professional; (iv) a means
for receiving from the health care professional a message for the
particular patient; and (v) a means for transmitting the message
from the health care professional to the patient. The analytic tool
may apply a set of rules to the data, which may be modified by the
health care professional, the patient, or both.
[0016] In another aspect, the systems of the invention may
comprise: (i) a memory unit; (ii) a display unit; (iii) an input
means; (iv) a communication means for communicating over a network;
(v) a processor interfaced with the memory unit, the display unit,
the input means, and the communication means, wherein the
processor, upon entering an activation mode, is configured to (a)
prompt the user to enter data related to the patient's treatment of
the disease and (b) store the data in the memory prior to exiting
the activation mode; and, upon re-entering the activation mode, is
configured to (c) prompt the user to enter follow-up data relating
to previously reported data; (d) transmit the data and follow-up
data over the network to one or more network addresses; and (vi) an
analysis tool having a second processor configured to (a') receive,
from the network, the patient data relating to the patient's
treatment of the disease and the follow-up data; (b') apply a
predetermined set of disease specific rules to generate an analysis
of the data and follow-up data; (c') generate a message based on
the analysis; (d') generate, upon request, a report based on the
analysis; and (e') transmit the message over the network. In some
embodiments, the message is transmitted to the patient interface
device. In some embodiments, the patient interface device comprises
a barcode reader and a touch screen.
[0017] The system may also comprise a database located at a network
location accessible to both the patient interface device and the
analysis tool.
[0018] In one series of embodiments, the patient interface device
may also comprise a drug delivery device, including, without
limitation, the ability to deliver drugs to treat hemophilia or
diabetes and/or a medical monitor for monitoring one or more
specific parameters related to the patient's disease, such as,
e.g., blood pressure, blood coagulation, haemoglobin, or
creatinine.
[0019] In another aspect, the invention encompasses a patient
interface device for assisting a patient in the treatment of a
disease, which is comprised of (i) a memory unit; (ii) a display
unit; (iii) an input means; (iv) a communication means; (v) a
processor interfaced with the memory unit, the display unit, the
communication means, and the input means, wherein the processor,
upon entering an activation mode, is configured to prompt the user
to enter data related to the patient's treatment of the disease is
configured to store the data in the memory prior to exiting the
activation mode; upon re-entering the activation mode, is
configured to prompt the user to enter follow-up data relating to a
previously reported data; and is configured to transmit the data
and follow-up data over the network to one or more network
addresses.
[0020] In another aspect, the invention encompasses a system for
analyzing patient data from one or more patients with a disease,
the system comprising: (i) a communication means for receiving data
collected contemporaneously with an administration of a
self-treatment or an onset of a symptom of the disease; (ii) a
processor configured to apply a predetermined set of criteria to
the data to generate an analysis of the data and configured to
generate a patient message based on the analysis; and (iii) a means
for transmitting the message based on the analysis over the network
to the patient.
[0021] In another aspect, the invention provides an electronic
database for assisting in the self-treatment of a disease, which is
comprised of: (i) a data element representative of the disease
being treated; and (ii) data from a plurality of patients who have
the same disease, the data relating to one or more symptoms of the
disease and self-administered treatments for the disease that are
administered for prevention of symptoms or in response to the
symptom(s), the data being collected contemporaneously with the
onset of the symptom(s) or the administration of the
treatments.
[0022] In another aspect, the invention provides a method for
assisting in the treatment of a patient with a disease comprising
the steps of: (i) recording data related to self-administration of
a treatment for the disease or a symptom of the disease
contemporaneously with onset of the symptom or the administration
of the self-treatment; (ii) transmitting the data over a network to
a database that is accessibly by an analysis tool; (iii) analyzing
the data with the analysis tool by applying a predetermined set of
rules to the data; (iv) generating a physician or care-giver report
and/or a patient message based on the analysis; and (v)
transmitting the message to the patient over the network.
[0023] The present invention provides numerous advantages to both
treating physicians and patients. In particular, for example in the
field of hemophilia physician and nurses can decrease the time
spent reviewing logs, established rules are flexible and adjustable
for each treatment center, and feedback to patients about their
treatment and use of infusion therapy is improved.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] FIG. 1 is an illustrative system drawing of one embodiment
of the system of the present invention.
[0025] FIG. 2 is a screen view for a PPC configured to work with
the system of embodiment 1.
[0026] FIG. 3 is a screen view illustrating an Infusion Data
Electronic Analysis System Icon that may be used to start select
the functions of the PPC that enable entry of hemophilia data.
[0027] FIG. 4 is a screen view illustrating how the present
invention may be used to configure a PPC to collect hemophilia data
from a patient.
[0028] FIG. 5 is a screen view illustrating exemplary prompts for
prompting a patient to enter data into the PPC.
[0029] FIG. 6 is a screen view illustrating the barcode entry
capability of the PPC.
[0030] FIG. 7 is a screen view illustrating barcode data entry.
[0031] FIG. 8 is an additional screen view illustrating barcode
data entry.
[0032] FIG. 9 is a screen view illustrating patient data entry
concerning data for infusion reasons.
[0033] FIG. 10 is a patient data entry screen for entering
follow-up data.
[0034] FIG. 11 illustrates a patient data entry screen for
inputting additional data.
[0035] FIG. 12 illustrates an immune tolerance data entry
screen.
[0036] FIG. 13 illustrates an additional data entry screen.
[0037] FIG. 14 illustrates a graphical interface for entering data
related to specific bodily regions.
[0038] FIG. 15 illustrates a graphic user input interface for
allowing data entry about bleeding in specific graphically depicted
body areas.
[0039] FIG. 16 illustrates a screen views for prompting patients
for complete and follow-up data related to reported conditions and
treatments.
[0040] FIG. 17 illustrates a prompt screen prompting a user to
complete data input.
[0041] FIG. 18 illustrates a screen that conveys which required
information is missing.
[0042] FIG. 19 illustrates a graphical data analysis.
[0043] FIG. 20 illustrates expanded data detail views.
[0044] FIG. 21 illustrates how data analysis may be exported to
spreadsheets or other graphical display means.
[0045] FIG. 22 illustrates a log-in screen for a website that
allows patient data to be entered.
[0046] FIG. 23 illustrates a data entry screen that is useable with
a website or handheld device.
[0047] FIG. 24 illustrates a data capture screen.
[0048] FIG. 25 illustrates a data entry screen adapted for use with
a hemophilia treatment system.
[0049] FIG. 26 illustrates a multi-patient data flagging
report.
[0050] FIG. 27 illustrates a screen showing individual patient data
records.
[0051] FIG. 28 illustrates a pop-up screen that can be used to send
patient alerts.
[0052] FIG. 29 illustrates a multi-clinic system used to compile
large data from different sources.
DETAILED DESCRIPTION OF THE INVENTION
[0053] The present invention provides methods and systems for
interactive home treatment of a patient suffering from a disease.
The methods are carried out by collecting information from the
patient in the form of structured data relating to the disease and
analyzing the information in a manner that facilitates appropriate
recognition of emergence of care issues and their treatment. The
invention further comprises providing feedback to the patient to,
e.g., optimize self-treatment, correct inappropriate patient
behavior, alert the patient and/or a clinic or medical professional
of the need for intervention, or to provide other beneficial
actions or outcomes. The invention provides the advantage of a
rationalized and personalized home treatment regimen and allows
more efficient use of medical resources, including therapeutic
treatments and medical professionals' time.
[0054] In one embodiment, the present invention may be particularly
useful in assisting in treatment of a chronic and/or episodic
disease or syndrome. The present invention is particularly useful
in treating a disease characterized by a periodic or sporadic
appearance of symptoms or fluctuations in severity of symptoms.
Non-limiting examples of such diseases or syndromes include
diabetes, hemophilia, asthma, chronic liver disease, hypertension,
acquired immune deficiency syndrome, multiple sclerosis, rheumatoid
arthritis, and other autoimmune diseases, epilepsy, chronic or
recurring viral infections (such as, e.g., chronic hepatitis C
infection and AIDS), chronic kidney insufficiency with home
dialysis, chronic myocardial insufficiency, chronic anticoagulant
treatment, Crohn's disease, ulcerative colitis, sickle cell anemia,
thallasemia, malaria, chronic substance abuse, cancer, chronic pain
syndrome, peripheral vascular disease and the like. While the
present invention is particularly well-suited for chronic and/or
episodic disease and syndromes, it may be used in monitoring and
assisting in the treatment of other diseases as well.
[0055] Treatment as used herein encompasses both preventive and
therapeutic activities as applied to expected or actual disease
episodes, respectively. Illustrative non-limiting examples of
preventive and therapeutic actions, respectively, include
administration of a coagulation replacement therapy to a person
known to be hemophiliac prior to a dental procedure or after
bleeding caused by such a procedure; administration of insulin to a
person known to be diabetic prior to, or after, mealtime; or
administration of a bronchodilator to a person known to be
asthmatic prior to exercise or after occurrence of symptoms caused
by exercise. Home treatment refers to an action that is performed
by an individual at a location removed from one at which
professional medical treatment is normally administered, such as,
e.g., a hospital, clinic, or doctor's office. Thus, home treatment
may take place at home, work, or school, as well as during leisure
activities, travel, and the like. Home treatment encompasses any
action taken by the patient (i.e., self-administration) or by a
surrogate, such as, e.g., by a parent for a child or by any other
person acting on behalf of the patient.
Collection of Structured Data:
[0056] In practicing the present invention, data are collected from
the patient that are relevant to the patient's chronic condition
and that may relate specifically to a current episode of the
condition. The collecting step may be achieved by direct input from
the patient and/or by input from a surrogate.
[0057] Typically, the data being collected encompass at least one,
and preferably more than one, of the following categories of
information: (i) the nature, severity, and/or timing of symptoms,
including one or more clinical indicators; (ii) one or more
predisposing factors that are predictive of onset of symptoms;
(iii) one or more actions related to treatment that have been
self-administered by the patient and/or administered to the patient
by a surrogate; (iv) treatment-specific information such as type
and amount of product used and batch number of product (v) one or
more changes in the symptoms, indicators, factors, or actions over
time; and (vi) patient assessment of response to treatment.
Optimally, data collection occurs contemporaneously with the onset
of symptoms or predisposing factors, the taking of action, or the
occurrence of changes as described above. As used herein,
"contemporaneously" refers to a time interval that is short enough
so that (i) the data being collected can be used in practicing the
invention or (ii) the data being collected are accurately recalled
by the patient. For example, in some embodiments, the data relating
to an episode are collected (and transmitted, see below)
sufficiently rapidly after the onset of symptoms to allow for
timely feedback (see below) that can be helpful to the patient. In
other embodiments, the data being collected are used to compile a
database.
[0058] As used herein, a "symptom" refers to any indication of
onset of disease that is apparent to the patient or a surrogate. A
"clinical indicator" encompasses an indication of disease onset
that relies on a measurement, such as, e.g., body temperature,
blood or peripheral glucose levels, blood hemoglobin, pain in a
muscle or joint, circumference of a joint or muscle, angular
movement of a joint, plasma bilirubin, or plasma creatinine. A
"predisposing factor" refers to any actions or circumstances that
are associated with onset of symptoms, such as. e.g., food intake
associated with hyperglycemia in a diabetic; injury, exercise or
surgical procedures associated with bleeding in a hemophiliac;
exercise associated with bronchoconstriction in an asthmatic; and
the like. A "change" refers to any difference perceived by the
patient or any detectable difference in a clinical measurement.
[0059] It will be understood that the particular types of data to
be collected from a patient will depend on the particular syndrome,
condition, or disease from which the patient suffers. It will be
understood that, for a particular syndrome, the types of data to be
collected and the way in which such data are structured can be
determined using ordinary skill in light of the guidance provided
herein.
[0060] In some embodiments, the disease being treated is hemophilia
and the structured data may include, without limitation, the
physical origin of a bleeding episode; the severity and timing of
bleeding; the amount and timing of self-administration of
coagulation replacement therapy; the time to arrest of the bleed,
and other details of how the bleeding episode was resolved. In
other embodiments, the disease being treated is diabetes and the
structured data may include, without limitation, blood glucose
levels at different times; the amount and timing
self-administration of insulin or other antihyperglycemic agent;
and the patient's dietary habits, i.e., specifics of food intake.
In yet other embodiments, the disease being treated is asthma and
the structured data may include, without limitation, the severity
and timing of wheezing, the forced expired volume, and the amount
and timing of self-administration of anti-asthma medication. In yet
other embodiments, the disease being treated is chronic liver
disease and the structured data may include, without limitation,
plasma liver enzymes measurements. In yet other embodiments, the
disease being treated is renal disease with home dialysis and the
structured data may include, without limitation, plasma creatinine
measurements. In yet other embodiments, the disease being treated
involves chronic anticoagulant treatment and the structured data
may include, without limitation, prothrombin time.
[0061] In practicing the present invention, the collecting step is
achieved using any local collecting device capable of receiving the
information from the patient and, preferably, conveying the
information to another location. Such collecting devices typically
contain a programmable microprocessor and/or a storage means
capable of storing the information. Non-limiting examples of
collecting devices include personal computers, personal digital
assistants or pocket personal computers ("PDA" or "PPC"),
telephones (preferably wireless), and "smart devices" (including,
without limitation, devices that incorporate clinical
monitors--such as, e.g., devices that monitor blood glucose,
hemoglobin, liver enzymes or bilirubin, or blood pressure--or
devices that deliver drugs or therapeutic agents--such as smart
injection devices, drug delivery pumps or inhaler, and the like.)
Preferably, the collecting device is portable and includes a
display feature that facilitates input of the information.
[0062] The information to be collected may be entered into the
collecting device by any means known in the art, such as, e.g.,
manually, using a keyboard or a touch-screen, or automatically,
e.g., using a scanner, bar-code reader, and the like. The
information may also include data that is entered directly from a
"smart device".
[0063] The collected data are then conveyed electronically (e.g.,
via phone lines, cellular, wireless, or satellite networks, or the
Internet) to a computer that is programmed to perform the data
analysis. In some embodiments, the data are first conveyed to
centralized core system, such as, e.g., a database stored in a Web
hotel, after which data relating to a particular patient are
conveyed specifically to the clinic or medical office with which
the patient is associated.
[0064] In other embodiments, the data are conveyed directly to the
clinic or medical office. The data analysis may be performed at any
appropriate location, including, without limitation, the
centralized core system or the clinic, with the proviso that the
results of the analysis should be available to be provided to the
patient, preferably in electronic form.
Data Analysis:
[0065] According to the present invention, clinical information
obtained from the patient relating to self-treatment, i.e., of a
chronic and/or episodic disease, is analyzed to identify the
presence or absence of predetermined patterns that indicate the
need for some type of intervention (which may also be carried out
using the system of the invention.) Such interventions include
instructions to the patient to modify the patient's self-treatment
regimen, such as, e.g., by instructing the patient to perform a
certain action or to refrain from a certain action, or by
instructing the patient to seek immediate treatment by a medical
professional. In some circumstances, the intervention may include a
contact to the patient initiated by the medical professional in the
absence of any direct request from the patient.
[0066] The analysis is conducted using one or more rules. A rule
refers to a single criterion, or a set of criteria, that identifies
a predetermined pattern in the data being collected, wherein the
pattern has been correlated to a need for certain actions or
decision-making, whether on the part of patient or a medical
professional. Such rules may be disease-specific (i.e., generally
applicable to anyone suffering from a particular disease);
group-specific (i.e., applicable to a subset of patients suffering
from that disease who, further, fulfill certain criteria related to
symptoms, behavior, etc.); and/or patient-specific (i.e., tailored
to an individual patient, based on the disease state, treatment
regimen and the patient's personal history of, e.g., symptoms,
behavior, and the like).
[0067] For example, a disease-specific rule may identify a
particular symptom that is known to indicate that any patient
reporting that symptom, rather than attempt self-treatment at home,
instead should contact a medical professional (e.g., call a doctor,
go to clinic or emergency room, etc.). Similarly, group-specific or
patient-specific rules may identify particular symptoms or
behaviors as indicating a need for a particular intervention,
whether by the patient or by a medical professional.
[0068] This analysis, specifically the application of general,
group-specific, and individual-specific rules to the
patient-entered data, results in the generation of responses which
are accessible to the patient and/or to a medical professional
involved in the patient's care.
[0069] For example, in the case of patients suffering from
hemophilia, the following non-limiting criteria may be used to
identify episodes in which the patient should not rely on
self-treatment but should instead be contacted by a medical
professional: (i) the interval in which the patient has not
reported any data (i.e., has not collected any data according to
the invention); (ii) the proportion of total bleeds that is
attributed to a single joint or body location; (iii) a threshold
number of bleeds in a given time period; (iv) the average time from
onset of bleed to self-treatment; and (v) a threshold number of
self-treatment infusions to treat one particular episode. (See,
Example 1 below).
Feedback:
[0070] In practicing the present invention, responses are fed back
to the patient and/or medical professional, preferably immediately
and preferably electronically. The responses are preferably
conveyed by the patient via the same local device that was used by
the patient to input the data. The responses may also be conveyed
to the clinic at the same time. Cumulative data for a particular
patient may be stored in a database in a centralized core system
and/or in a database at the clinic.
[0071] As is shown Figure in 19, a graphical view may be used to
show, for example hemophilia infusion data. Infusion data, or other
data, may be graphically viewed for an individual patient, groups
of patients, and/or a particular product. Individual data, such as
individual infusion data, may be expanded to view details, as is
shown in FIG. 20. Moreover, established output graphs may be used
to make viewing of the majority of important issues regarding
analysis of infusion data.
[0072] Additional advantages of the present invention include the
ability to easily export data to spreadsheets, such as
Microsoft.RTM. Excel.RTM., for further analysis outside of
established output functions.
[0073] Additionally, clients utilizing the system can be given
access to some graphic infusion data analysis through personalized
secure websites. For example, a patient website can be established
in which the patient can view their own data. The data may include
data inputted by the patient, as well as data inputted by a clinic.
A third party medical practitioner can also be given access to the
data. A particular advantage of the present invention is that both
clinical data and patient inputted data can be stored at one
location, manipulated, and analyzed, thereby aiding a practioner in
optimizing a treatment regimen for a particular patient.
[0074] In addition, the ability to view both the patient-inputted
data and the clinic-inputted data can allow for pharmacoeconomic
studies to be done on a patient-by-patient basis as an approach to
optimize treatment. Additionally, the viewing of both types of data
can be used to detect and correct non-compliance of a treatment
regimen by a patient.
[0075] As the data often contain private medical information,
security is an issue. Some security measures within the scope of
the present invention include: [0076] 1) entering data into the PPC
with a username and password; [0077] 2) entering the data into a
website with a username and password; [0078] 3) encrypting and
otherwise securing transmission of the data; [0079] 4) allowing
each center to have exclusive access to their patient data; and
[0080] 5) Allowing the client and only the treatment center the
ability to access the data, unless the client grants rights to a
third party.
Iterative Analyses and Development of Rules:
[0081] In some embodiments, the present invention encompasses
repeated applications of the above-described method, i.e., repeated
steps of collecting patient-entered data and analyzing the data
using rules (with or without the step of feeding back to patient
the results of the analysis). It will be understood that such
iterative application of the methods of the invention can be used
to detect additional patterns of correlation between, e.g.,
particular symptoms or patient behavior and particular clinical
outcomes. Such patterns then become useful to develop and refine
additional disease-specific, group-specific, and/or
patient-specific rules.
[0082] In one aspect, the present invention encompasses methods for
the development of rules that can be used for data analysis as
described above. The methods are carried out by the steps of:
[0083] (i) collecting from a plurality of patients suffering from a
particular chronic and/or episodic syndrome patient-specific and
episode-specific data, wherein the data relate to one or more of:
(a) the nature, severity, and/or timing of the patient's symptoms,
including one or more clinical indicators; (b) one or more
predisposing factors that are predictive of onset of symptoms for
that patient; (c) one or more actions taken by the patient related
to treatment that have been self-administered by the patient and/or
administered to the patient by a surrogate; (d) one or more changes
in the symptoms, indicators, factors, or actions over time
following initial onset of an episode, to create a patient
database; and (e) patient assessment of response to treatment;
[0084] (ii) establishing correlations between one or more of
(a)-(e) and the outcome of the episodes, wherein the outcome
involves resolution, continuation, development, or other change in
the symptoms; and
[0085] (iii) identifying actions taken or not taken by the patient
or a medical professional that were helpful or deleterious in
achieving resolution of the symptoms; and
[0086] (iv) repeating steps (i)-(iii) above to provide
predetermined patterns.
[0087] In one series of embodiments, the predetermined patterns
that are derived from the above analysis may identify different
sub-categories of patients that exhibit particular symptoms and/or
respond to particular interventions, thereby creating
group-specific rules.
[0088] In another series of embodiments, the above method may be
used to customize rules for a particular patient. In these
embodiments, (i) data are collected from a single patient relating
to a plurality of episodes; (ii) correlations are established
between and among the collected data (such as, e.g., a correlation
between the interval between occurrence of a particular symptom and
the outcome of the episode), as well as between the
patient-specific data and larger patient databases. (The larger
patient databases to which the patient-specific data are compared
may comprise, without limitation, the entire population of patients
suffering from the disease, or, alternatively, a sub-group of
patients previously identified using the methods of the invention.)
In this manner, the rules are modified to provide a more tailored
feedback protocol applicable to that particular patient. For
example, with one particular patient, the appearance of a
particular symptom may signal the need for that patient to be
contacted by a medical professional immediately, whereas, in
another particular patient, the number of individual episodes
occurring within a particular time period may signal that same
need.
[0089] In another series of embodiments, the methods of the
invention may be used as an important part of an ongoing analysis
of resource utilization by a particular patient or group of
patients suffering from a similar disorder.
[0090] It will be understood that correlations and patterns may be
derived from conventional statistical analyses well-known in the
art, with or without input from medical or other professionals
relating to anecdotal or other insights or expectations of disease
mechanisms and patient behaviors.
[0091] It will also be understood that a rule developed using the
methods of the invention may be further validated by testing if
application of the rule to specific collected data results in (i)
the identification of, e.g., problematic patients or episodes (ii)
more successful resolution of an episode or episodes, (iii)
reduction in the number of episodes in a particular patient or in a
group of patients and/or any indication of better clinical
management of disease in a particular patient or in a group of
patients. Such testing may be followed by repeating the above steps
in order to further refine a particular rule.
[0092] While some situations call for a complex set of rules,
simpler flagging rules may, in certain cases, be adequate. For
example, the following rules have shown to be adequate in assisting
in the self-treatment of hemophilia. The bracketed values may be
modified by an individual center.
[0093] Rule 1. No reporting from patient in {30 days}
[0094] Rule 2. The number of joint bleeds in one location exceeds
{25%} of total number of bleeds (for the last six months).
[0095] Rule 3. The total number of bleeds exceeds {4} during a
period of 30 days.
[0096] Rule 4. The average time from onset of bleed to infusion
exceeds {3 hours}(average for the last six months)
[0097] Rule 5. More than {2 infusions} for one particular bleed
[0098] A "please call center" message is generated and sent to the
patient. In addition, pop-up boxes may be used to communicate
critical information to a patient.
Systems for Interactive Home Treatment
[0099] As is shown in FIG. 1, the system of the present invention
may include a patient interface device, such as a Pocket Personal
Computer ("PPC"). The PPC may be any intelligent portable device,
including--but not limited to--a personal digital assistant, a
programmable cellular phone, a smart medical device (such as a drug
delivery device or a medical monitor), or any other portable device
that has a processor and memory, an input means, a display means,
and a communication means. Preferably, the PPC is a handheld
electronic device with bi-directional communication capability. It
may have wireless communication capabilities or it may have an
interface for connecting it to a standard wired network, existing
phone system, LAN, WAN, or the like.
[0100] The processor is preferably capable of being programmed to
prompt the user for certain information and to input certain data
related to that information via the input means, process the data,
and store the data locally, at least temporarily, and then transmit
at least a portion of the information inputted by the patient to
another location. In one embodiment, the PPC may be a standard
personal digital assistant running on the Window CE software, such
as, e.g., HP jornada 560 personal digital assistant (Product no:
F2915A version ABA A1Q3 using Windows CE ver. 1.0-1.1) or a Compaq
iPAQ Pocket PC (Product no: 269808-021, Model 3950 (S/N:
4G26KVL1Y9PH Compaq) using Windows CE version 1.0-1.1)
[0101] The input means may comprise a keyboard, a barcode reader, a
microphone and associated speech recognition software, or any other
mechanism for allowing data to be entered by the patient.
[0102] In some embodiments, the input means may include a graphic
user interface. For example, where the device is configured for use
in the self-treatment of hemophilia, the PPC may be configured to
display various body parts. A user experiencing a bleeding episode
may be prompted to select the bodily area where a bleeding episode
is occurring by touching a screen having a depiction of the human
body. FIGS. 2-18 illustrate some examples of screen views for a PPC
configured to assist in the treatment of hemophilia. Of course, the
PCC may be configured allow for user-friendly inputting of data
relevant to other diseases that are to any extent self-treated.
Attached as Appendix 1 is an example of a user manual for a PPC
programmed to assist in the treatment of hemophilia.
[0103] The PPC preferably communicates with a database over a
network, such as the Internet. In one embodiment, the communication
is performed in a secure manner using encryption technology or
other means for secure transmission over public networks. The
database may be located at a Web-hotel or other facility. In some
embodiments, as is shown in FIG. 1, at least a portion of the
database is reproduced and stored at a clinic or other treatment
facility. The local database at the treatment facility may be
accessed by an analytic tool. The analytic tool may be any
conventional PC or any device that may be programmed or otherwise
configured to process and/or manipulate the data in the database. A
personal computer is particularly well suited for use as an
analytic tool, such as, e.g., an IBM Personal Computer 400 GL
(166-megahertz or higher Pentium-compatible CPU and 4 megabyte Ram,
128 or more RAM and 2 GB or larger hard disk using the Microsoft
Windows 2000 professional UK version operating system. The analytic
tool may physically reside in a treating professional's clinic or
offices. However, the exact location of the tool is not critical.
For example, in some embodiments, the analytic tool may reside
within or under the control of an entity with a relationship with
the treating physician, such as for example, the IT department of a
pharmaceutical company.
[0104] Where the analytic tool is not physically located at the
treating professional's location, the treating professional may
access the tool via a network such as the Internet. Thus, the
analytic tool may be web-enabled allowing a treating physician or
other health care professional to access the tool from virtually
anywhere. One of the many advantages of web-enabling the system of
the present invention is that a physician who sees patients in both
an outpatient clinical setting or private office can access the
tool in that setting as well as when administering to patients in a
hospital. The analytic tool, regardless of where it resides, may be
programmed to apply the predetermined rules to the data. In some
embodiments, the analytic tool is also configured to allow a health
care professional to modify the rules based on specific needs
and/or experiences of a particular patient.
[0105] In an embodiment of the present invention, one or more sets
of rules are developed to analyze the data collected by the
analytic tool. If certain conditions, as defined in the rules, are
satisfied, a message is sent either to the health care provider or
directly to the patient. In one embodiment, where the message is
sent to the health care provider, the health care provider may
create a message and utilize the infrastructure of the system of
the present invention to send a message to the patient via the
patient's handheld device. The message might be a detailed message
for self-administering treatment or it may be a simple message such
as "Call Doctor."
[0106] The analytic tool is preferably configured to allow
modification to the set or sets of rules by one or more treating
healthcare professionals. Typically, default rules will be
initially applied to the data, but over time they may be modified
based on particular experiences of the patients and the treating
professionals. By allowing the rules to be modified as experience
is gained with a particular patient or group of patients, the tool
may assist in developing a baseline for a particular patient,
comparing that baseline against similarly situated patients,
modifying the particular patient or group of patients treatment
and/or behavior, and more allow for more effective management and
treatment of the disease.
[0107] In some embodiments of the present invention, a patient
website may be used in addition to a PPC or in place of a PPC. The
website advantageously allows the patient to view the patient's own
data and also allows the patient to input additional data. The
website may be secured so that it may only be accessed by the
patient, a clinic and/or a medical practitioner authorized by the
patient. Additionally, the site is preferably secured with a
password or other well-known security technologies and encryption
may be employed before data are sent over a public network.
[0108] FIG. 22 shows a log-in screen for a web-enabled system that
incorporates password and encryption protection. FIG. 23 shows one
example of a data entry screen for use with either the PPC or the
website based embodiments. Data may be analysed to determine the
number of injury related infusions, severity of bleeding event,
time from bleeding to institution of infusion therapy, etc. FIG. 24
shows that the present invention also may provide a means for a
patient to input data related to assessment of a response to each
infusion or an overall bleeding episode, for example, when the
system is applied to hemophilia.
[0109] FIG. 25 shows a screen that may be used on either the PPC or
a website for facilitating data entry and FIG. 26 depicts a data
capture screen that allows linkage of data to events, procedures or
treatment plans that allow for pharmacoeconomic analysis. The data
may be analyzed to determine compliance with treatment regimen or
intervention plans. For example, FIG. 26 shows how transmitted data
are analyzed on an ongoing basis by comparison and determination of
deviation from established rules. The system rules are easily
adaptable to each treatment centers practice and standards of care.
Data are typically flagged when they are outside of established
parameters and flagged data are easily visible and allow treatment
center staff to communicate to the client.
[0110] Advances in software and Internet technology make it
possible to run the patient client software not only on a PPC or
similar device, but also on a centralized server. For example,
Microsoft dot.net applications allow the software to be
web-enabled. This, in some embodiments, allows for less robust
patient-client devices to be used. It also allows the patient to
access the patient client software via any device capable of
communicating and operating on a network on which the server
containing the patient-client software resides. Thus, in some
embodiments, the patient only needs access to the Internet to use
some of the systems and methods of the present invention.
[0111] In addition, as shown in FIG. 27, individual patient
infusion records may be viewed as abbreviated episodes.
[0112] Additional advantages and capabilities of the present
invention are too numerous to list herein. However, these
advantages and capabilities will be readily apparent to those
skilled in the art. For example, and without limitation, when the
present invention is utilized in the field of hemophilia care:
[0113] data can be analyzed on an ongoing basis by comparison, and
determination of deviations from established rules can be
analyzed;
[0114] system rules can easily be adapted to reach treatment
centers' practice and standards of care;
[0115] data can be flagged when they are outside established
parameters; and flagged data are easily visible and allow treatment
center staff to communicate with the client.
[0116] Moreover, flagging rules can be used to provide automated
messages to both the patient and the patient's healthcare provider.
In response to these messages, additional steps may be taken by
either the patient or the healthcare provider. As a result of this
early intervention, treatment may be modified and optimized and, in
some cases, lengthy or expensive hospital based or clinic based
intervention can be avoided. Thus, the present invention provides a
means for reducing long term medical expenses while optimizing home
treatment.
[0117] In addition patient alerts can be used to notify patients
when a condition requires medical treatment from qualified
professionals. FIG. 28 shows how a pop-up box can be used to
provide this alert.
[0118] A particularly useful feature of the present invention is
that data can automatically be stored within a network environment
from different patients and clinics. Patient folders can be
established for each patient. And these folders may be
automatically integrated into a larger database. FIG. 29 shows one
such embodiment illustrating this novel advantage of the present
invention.
[0119] All patents, patent applications, and literature references
referred to herein are hereby incorporated by reference in their
entirety.
[0120] Many variations of the present invention will suggest
themselves to those skilled in the art in light of the above
detailed description.
[0121] As discussed above, the present invention greatly improves
treatment, patient quality of life and the ability to do research
and in particular, perform pharmacoeconomic studies such as those
described in H. Ekert et al. "Cost-utility analysis of recombinant
factor VIIa (NovoSeven.RTM.) in six children with long-standing
inhibitors to factor VIII and IV Haemophilia (2001), 7,270-285;
Economic Costs of Diabetes in the U.S. in 2002, American Diabetes
Association Diabetes Care, volume 26, number 3, March 2003; and
Isaac Odeyemi, Julian Guest, Modelling the economic impact of
recombinant activated Factor Vii and activated prothrombin-complex
concentrate in the treatment of mild to moderate bleed in adults
with inhibitors to clotting Factors VIII and IX at a comprehensive
care centre in the UK, Journal of Medical Economics, 2002; 5:0-0;
the contents of all three are hereby incorporated by reference.
[0122] The following examples are intended as non-limiting
illustrations of the present invention.
Example 1
Rules for Interactive Home Treatment of Hemophilia Patients
[0123] The following describes the development and application of
rules for use of the present invention by patients suffering from
hemophilia who, in response to bleeding episodes or for prevention
of bleeding episodes, self-administer Factor VIII, Factor IX, or
bypassing products in patients with inhibitors. [0124] I. The
following rules were used: [0125] 1. An interval of at least A(=7)
days since the patient last entered data using the system of the
invention. (The purpose of this rule is early detection of patients
not complying with reporting obligations.) [0126] 2. The number of
joint bleeds in one location exceeds B(=20) % of total number of
joint bleeds. (The Purpose of this Rule is to Detect Early Target
Joint Development.) [0127] 3. The total number of bleeds exceeds
C(=4) during a period of D (=30) days. (The purposes of this rule
are (i) detection of "break-through" bleeds in patients on
prophylaxis regimens and (ii) early detection of changes in
patient's disease activity/life style.) [0128] 4. The average time
between the onset of a bleed to infusion exceeds E (=180) minutes.
(The purposes of this rule are; (i) to reveal suboptimal resource
utilization and (ii) to prevent target joint development.) [0129]
5. More than F (=6) infusions were self-administered to treat one
particular bleed. (The purposes of this rule are: (i) to reveal a
patient's misinterpretation of his/her clinical situation and (ii)
to detect habits of overtreatment.) [0130] 6. Particular sites of
bleeding (The purpose of this rule is to insure that bleeding in
certain sites results in a call by the patient to the treatment
center.) [0131] II. Data was collected from a group of 10 patients
over a period of two months. Data was analyzed using Anova Multiple
Regression Analysis software. Patients were also differentiated by
their clinical situations, i.e., patients having coagulation factor
inhibitors; patients requiring on-demand treatment, and patients
employing prophylactic coagulation factor VIIa self-administration.
[0132] III: After two months, the value of A was calculated as the
optimal time interval for the system to detect variant behavior as
early as possible using multiple regression analysis of pooled
patient data. Regression analysis between the total amount of
product infused and the time from onset of bleed to infusion in
pooled patient data revealed a deviation from a straight line which
allowed estimation of the value of E.
[0133] Regression analysis of patients developing target joints and
of patients not developing target joint compared to the % bleeding
intensity in one particular joint allows for optimal estimation of
values of B. The observation time could be several months to
several years.
[0134] Similarly, regression analysis of patient developing
progressively intensive bleeding manifestation and patients having
a constant bleeding frequency level allows for calculation of the
total number of bleeds C over a fixed period of time D that will
represent the diversion value between the two modes of disease
development.
[0135] All patents, patent applications, and literature references
referred to herein are hereby incorporated by reference in their
entirety.
[0136] Many variations of the present invention will suggest
themselves to those skilled in the art in light of the above
detailed description.
* * * * *